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IBM Works To Avoid FDA Oversight For Its Watson Software

Posted on October 25, 2017 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

I live in DC, where the fog of politics permeates the air. Maybe that’s given me more of a taste for political inside baseball than most. But lest the following story seems to fall into that category, put that aside – it actually involves some moves that could affect all of us.

According to Stat News, IBM has been lobbying hard to have its “cognitive computing” (read: AI) superbrain Watson exempt from FDA oversight. Earlier this year, eight of its employees were registered to lobby Congress on this subject, the site reports.

Through its Watson Health subsidiary, IBM has joined the crowded clinical decision support arena, a software category which could face FDA regulation soon.

Historically, the agency has dragged its heels on issuing CDS review guidelines. In fact, as of late last year, one-third of CDS developers were abandoning product development due to their uncertainty about the outcome of the FDA’s deliberations, according to a survey by the Clinical Decision Support Alliance.

Now, the agency is poised to issue new guidelines clarifying which software types will be reviewed and which will be exempt under the provisions of the 21st Century Cures Act. Naturally, IBM wants Watson to fall into the latter category.

According to Stat News, IBM spent $26.4 million lobbying Congress between 2013 and June 2017. While IBM didn’t disclose how much of that spent on the CDS regulation issue, it did tell the site that it was “one of many organizations, including patient and physician groups, that supported a common sense regulatory distinction between low-risk software and inherently higher-risk technologies.”

IBM also backed a bill known as the Software Act, which was opposed by the FDA office in charge of device regulation but backed enthusiastically by many software makers. The bill, which was first introduced in 2013, specified that health software would be exempted from FDA regulation unless it provided patient-specific recommendations and posed a significant risk to patient safety. It didn’t pass.

Now, executives with the computing giant will soon learn what fruit their lobbying efforts bore. The FDA said it intends to issue guidance documents explaining how it will implement the exemptions in the 21st Century Cures Act during the first quarter of next year.

No matter what direction it takes, the new FDA guidance is likely to be controversial, as key regulatory language in the 21st Century Cures Act remains open to interpretation. The law includes exemptions for advisory systems, but only if it’s they allow “health care professional to independently review the basis for such recommendations.”  Lawyers representing software makers told Stat News that no one’s sure what the phrase “independently review the basis” means, and that’s a big deal.

Regardless, it’s the FDA’s job to figure out what key provisions in the new law mean. In the meantime, waiting will be a bit stressful even for giants like IBM. Big Blue has made a huge bet on Watson Health, and if the FDA doesn’t rule in is favor, it might need a new strategy.

FDA Under Pressure To Deliver Clinical Decision Support Guidelines

Posted on November 10, 2016 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

The world of clinical decision support technologies may change soon, as the FDA may soon be releasing guidelines on how it will regulate such technology. According to a new report in Politico, the agency has been working on such guidelines since 2011, but it’s not clear what standards it will use to establish these rules.

Software vendors in the CDS business are getting antsy. Early this year, a broad-based group known as the Clinical Decision Support Coalition made headlines when it challenged the agency to clarify the scope of CDS software it will regulate, as well as what it will require from any software that does fall under its authority.

At the time, the group released a survey which found that one-third of CDS developers were abandoning CDS product development due to uncertainty around FDA regulations. Of CDS developers that were moving ahead despite the uncertainty, the only two-thirds were seeing significant delays in development, and 20% of that group were seeing delays of greater than one year.

The delay has caught the attention of Congress, where Sens. Orrin Hatch (R-Utah) and Michael Bennet (D-Colo.) have filed the Medical Electronic Data Technology Enhancement for Consumers’ Health Act, legislation designed to resolve open questions around CDS software, but the problem still remains.

The FDA has had a research project in place since late 2014 which is creating and evaluating a CDS system for safe and appropriate use of antibiotics. The researcher-developed system generates alerts when a provider prescribes an antibiotic that poses a risk of serious cardiac adverse events for specific patients. Two of the 26 hospitals in the Banner Health network are participating in the study, one of which will use the system and the other which will not. The results aren’t due until April of next year.

It’s hard to say what’s holding the FDA up in this case, particularly given that the agency itself has put CDS guidance on his list of priority projects. But it could be a simple case of too much work and too few staff members to get the job done. As of late last year, the agency was planning to fill three new senior health scientist positions focused on digital health, a move which could at least help it keep up with the flood of new health technologies flooding in from all sides, but how many hours can they work?

The truth is, I’d submit, that health IT may be moving too quickly for the FDA to keep up with it. While it can throw new staff members at the problem, it could be that it needs an entirely new regulatory process to deal with emerging technology such as digital health and mobile device-based tools; after all, it seems to be challenged by dealing with CDS, which is hardly a new idea.